Molecules / Nelarabine

Nelarabine API manufacturers

CAS 121032-29-9 ATC L01BB07 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
33
finished-dose makers across 18 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for nelarabine, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Alembic Pharmaceuticals

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for nelarabine, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Biophore India Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for nelarabine, filing since 2020. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

ScinoPharm Taiwan

Taiwan
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for nelarabine, filing since 2023. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Synbias Pharma

Ukraine
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for nelarabine, filing since 2016.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Sionc Pharmaceuticals

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for nelarabine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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3 more manufacturers hold filings for nelarabine

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

ScinoPharm TaiwanSynbias PharmaSionc Pharmaceuticals
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Contract manufacturers (1)

Biophore India Pharmaceuticals India

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (6)

Amneal United States Dr. Reddy's Laboratories India Zydus Lifesciences India Gland Pharma India Novartis Switzerland Sandoz Switzerland

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

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Also on this molecule

Recalls 2 Finished dose 6 Contract mfrs 1

By country

India 5